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Model Number X060-0320 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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A visual assessment of the returned system screwdrivers showed instruments with repeated use as identified by worn laser markings and surface scratches.The distal tips of the three complaint instruments were fractured as reported.Functionality assessments were not performed due to the damaged condition of the system screwdrivers, which were removed from distributable inventory.A dhr review was performed for complaint lot# 040322 and there were no manufacturing anomalies identified.The device lot met all required specifications prior to being released to distributable inventory.Lot# 040322 has been available for distribution since (b)(6) 2012.It may be possible for the distal tip of a screwdriver to fracture if excessive rotational force was applied.It may also be possible for the distal tip of a screwdriver to fracture if it was not fully seated in the head of the screw prior to being rotated.The returned torque-limiting handles were tested by the manufacturer on a torque-calibration device, and one of the returned torque-limiting handles did not appropriately limit applied torque.It cannot be determined which screwdrivers were attached to the out of specification torque-limiting handle when the malfunctions occurred.The complainant also reported that system screwdriver malfunctions had occurred when a surgeon attempted to final lock the implant while the distal tip of the screwdriver was not fully engaged in the set screw.There have been two other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this instrument for complaints from the field.This report is associated with 3005031160-2022-00027 and 3005031160-20220-00032.
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Event Description
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The manufacturer received notification on (b)(6) 2022 of two system screwdrivers that malfunctioned during a surgical procedure.Replacement instruments were provided to the complainant, and a return authorization was issued for return of the complaint instruments.On (b)(6) 2022 two system trays containing a total of three screwdrivers with malfunctioned distal tips were received at the manufacturer for complaint assessment.There were no known patient complications associated with this complaint.Repeated attempts to collect relevant complaint incident information were made, with minimal information provided.
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Search Alerts/Recalls
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